Comparison of tamoxifen with danazol for treatment of cyclical mastalgia.
This study evaluates the benefits and side-effects of two drugs (tamoxifen or danazol) used randomly in women with severe cyclical mastalgia. Ninety-three patients with severe cyclical mastalgia of more than 6 months duration were randomly selected for treatment with tamoxifen (32 women), danazol (32 women) or placebo (29 women) for six consecutive cycles. A standard protocol was used, which included pain relief as measured by linear analog, side-effects and cost. Statistical analysis was performed using the non-parametric Mann-Whitney U or Kruskall-Wallis tests and Student's t-test. As measured by linear analog scoring, pain relief was achieved in 23/32 (72%) of those receiving tamoxifen, 21/32 (65%) of those taking danazol (p < or = 0.001) and 11/29 (38%) of those taking placebo. Twelve months after the end of treatment, 17 (53%) women who received tamoxifen were still free of symptoms, as compared with 12 (37%) of the danazol-treated patients (p < 0.001) and none of the placebo-treated patients. These results suggest that tamoxifen is highly efficaceous and cost effective for the management of severe cyclical mastalgia.
Kontostolis
E
E
Department of Obstetrics and Gynecology, Ioannina-University Hospital, Greece.
Stefanidis
K
K
Navrozoglou
I
I
Lolis
D
D
D000328:Adult; D015331:Cohort Studies; D003613:Danazol / Q000009:adverse effects / Q000627:therapeutic use*; D004965:Estrogen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D011446:Prospective Studies; D012016:Reference Values; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*
D004965:Estrogen Antagonists; D013629:Tamoxifen; D003613:Danazol